Wound healing system and method of use

ABSTRACT

The present invention is a wound healing system and method of use to address the healing of wounds found on a foot of a patient. The wound healing system provides an apparatus and method of protecting and healing foot wounds, especially foot ulcers of diabetic patients. The wound healing system can be used on a wound found on almost any area of the bottom of a foot. The wound healing system includes a method of reducing the mechanical load on a wound, allowing the patient to walk while the system is in use, allowing the patient to access and attend to the foot, allowing different methods of treating a foot wound, and providing a kit with which medical personnel can easily fit the patient with the apparatus.

This application is a divisional patent applcation of and claimspriority to U.S. patent application Ser. No. 09/817,412 filed Mar. 26,2001 now U.S. Pat. No. 6,610,897.

BACKGROUND

It is known that foot wounds in diabetic patients represent asignificant public health problem throughout the world. Treatment ofsuch wounds has been focused on amputation and not on limb salvage, asmany of the wounds have not been properly treated. Improper treatmentcan be attributed to lack of an easy treatment method and inconvenienceto the patient in using current methods. There is a need to preventamputation by healing such wounds at an early stage.

Foot wounds in patients with diabetes develop because of a processcalled neuropathy. Diabetes causes loss of sensation such that skininjury and complete breakdown (ulcer) can develop with no or minimalpain. These wounds tend not to heal because of ongoing mechanical traumanot felt at all by the patient as painful. Such wounds can only behealed by protecting them from mechanical trauma. Small plantar ulcersin diabetic patients are usually seen by primary care practitioners andendocrinologists. The present method for healing plantar ulcers is atotal contact cast for the foot, which provides complete mechanicalprotection. This method is not ideally suited for either of thesepractice settings, because it requires skilled and specialized care inapplication, along with frequent follow up. Most patients perceive thecast to be an inconvenience at the early stages of such a wound, whileperceiving that such a wound is not serious matter. The alternative tothe cast is to ask the patient to be non-weight bearing through the useof a wheelchair, crutches, or a walker, which provide completemechanical protection only with complete patient compliance. Thisalternative rarely proves to be effective in healing wounds within areasonable time period, due to human nature.

What is needed is a treatment that primary care physicians or theirstaff can employ to treat ulcers and other wounds on the feet. Also,what is needed is a treatment that allows patients to be able tocontinue their active lives when they have a foot wound, yet promoteshealing of the wound. Unfortunately, due to human nature, the perceivedinsult and inconvenience of using healing methods that are currentlyavailable is sufficient to discourage their use by the patient.

It is an object of the present invention to provide a wound healingsystem which reduces mechanical load on a wound.

It is another object of the present invention to provide a wound healingsystem which is easy to employ by medical personnel.

It is another object of the present invention to provide a wound healingsystem in which will not be rejected by the patient.

SUMMARY OF THE INVENTION

The present invention is a wound healing system and method of use toaddress the healing of wounds found on a foot of a patient. The woundhealing system provides an apparatus and method of protecting andhealing foot wounds, especially foot ulcers of diabetic patients. Thewound healing system includes a load relieving dressing, foot pad and adressing opening. The load relieving dressing is attached to an areaabout the wound of the foot, whereby the load relieving dressingprovides support to the foot in the area and relieves load on the wound.The foot pad fits into footwear. The dressing opening is in the foot padand is sized to securely receive the load relieving dressing.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an exploded view of a kit containing a wound healing systemaccording to the present invention;

FIG. 2 is an exploded view of the wound healing system in use accordingto the present invention;

FIG. 3 is an exploded view of a load relieving dressing and a footaccording to the present invention;

FIG. 4 is a perspective view of the load relieving dressing and a footaccording to the present invention;

FIG. 5 is a perspective view of an example of the load relievingdressing according to the present invention;

FIG. 6 is a perspective view of another example of the load relievingdressing according to the present invention;

FIG. 7 is a perspective view of another example of the load relievingdressing according to the present invention;

FIG. 8 is a perspective view of another example of the load relievingdressing according to the present invention;

FIG. 9 is a perspective view of another example of the load relievingdressing according to the present invention;

FIG. 10 is a perspective view of another example of the load relievingdressing according to the present invention;

FIG. 11 is a perspective view of another example of the load relievingdressing according to the present invention;

FIG. 12 is a cross-sectional view of an example of the load relievingdressing according to the present invention;

FIG. 13 is a cross-sectional view of another example of the loadrelieving dressing according to the present invention;

FIG. 14 is a cross-sectional view of another example of the loadrelieving dressing according to the present invention;

FIG. 15 is a cross-sectional view of another example of the loadrelieving dressing according to the present invention;

FIG. 16 is an exploded view of a load relieving dressing on a foot beingplaced in an uncut foot pad according to the present invention;

FIG. 17 is a perspective view of a load relieving dressing on a footplaced in the uncut foot pad according to the present invention;

FIG. 18 is a perspective view of a load relieving dressing on a footplaced in a cut foot pad according to the present invention;

FIG. 19 is another exploded view of a load relieving dressing on a footbeing placed in an uncut foot pad according to the present invention;

FIG. 20 is another perspective view of a load relieving dressing on afoot placed in the uncut foot pad according to the present invention;

FIG. 21 is another exploded view of a load relieving dressing beingplaced on a foot, ready to be placed in an uncut foot pad according tothe present invention;

FIG. 22 is another exploded view of a load relieving dressing on a footbeing placed in an uncut foot pad according to the present invention;

FIG. 23 is another perspective view of a load relieving dressing on afoot placed in an uncut foot pad according to the present invention;

FIG. 24 is another perspective view of a load relieving dressing on afoot placed in a cut foot pad according to the present invention;

FIG. 25 is another perspective view of a load relieving dressing on afoot placed in an uncut foot pad according to the present invention;

FIG. 26 is another perspective view of a load relieving dressing on afoot placed in a cut foot pad according to the present invention;

FIG. 27 is another exploded view of a load relieving dressing beingplaced on a foot, ready to be placed in an uncut foot pad according tothe present invention;

FIG. 28 is another exploded view of a load relieving dressing on a footbeing placed in an uncut foot pad according to the present invention;and

FIG. 29 is another perspective view of a load relieving dressing on afoot placed in a cut foot pad according to the present invention.

DETAILED DESCRIPTION OF THE INVENTION

The present invention is a wound healing system and method of use toaddress the healing of wounds found on a foot of a patient. The woundhealing system provides an apparatus and method of protecting andhealing foot wounds, especially foot ulcers of diabetic patients. Thewound healing system can be used on a wound found on almost any area ofthe bottom of a foot. The wound healing system includes a method ofreducing the mechanical load on a wound, allowing the patient to walkwhile the system is in use, allowing the patient to access and attend tothe foot, allowing different methods of treating a foot wound, andproviding a kit with which medical personnel can easily fit the patientwith the apparatus.

FIG. 1 shows the wound healing system 10 in a kit form which can beutilized by medical personnel. The main components of the wound healingsystem 10 are a load relieving dressing 12 and a foot pad 14 whichreceives the load relieving dressing 12. Other components which can beincluded as part of the kit are a boot 15, cushion pad 16, surgicalblade 18, tweezers 20, scissors 22, ruler 24, wound treatment pads 26,wound cleanser 28 and educational materials 30. The boot 15 is used toallow the patient to be mobile, without being restricted to a non-weightbearing device, such as a wheelchair or crutches. Other types offootwear can be substituted for the known medical boot 15 that is shown.The cushion pad 16 provides additional cushioning in the boot 15. Thesurgical blade 18, tweezers 20, wound treatment pads 26 and woundcleanser 28 are attending materials instruments for treating a wound ona foot. The ruler 24 or other type of measuring instrument is forassessing the size of the wound, as well as sizing the foot and foot pad14. The scissors 22 is a cutting instrument for cutting the foot pad 14according to the size of the foot and the boot 15. The educationalmaterials 30 are for educating the user of the kit and the patient withthe foot wound as to the proper use of the wound healing system 10. Theeducation materials 30 can include a CD for use on a computer, videotape and booklets. Foam board 32 is also show as part of the kit and issimply used to separate materials in a box 34 containing the kit.

FIG. 2 shows the wound healing system 10 used on a typical foot wound36, such as a plantar ulcer of a diabetic patient. Shown in FIGS. 2-4 isa load relieving dressing 12 applied to a bottom area of a foot 38 andabout the wound 36. The load relieving dressing 12 supports the area ofthe foot 38 to which the load relieving dressing 12 is applied. The loadrelieving dressing 12 is usually applied to the foot 38 using some typeof adhesive. The load relieving dressing 12 is inserted into a dressingopening 40 of the foot pad 14, when the foot 38 is placed on the footpad 14. The dressing opening 40 is depicted in the figures as a hole,but can merely be an opening in the foot pad 14, which receives the loadrelieving dressing 12. The foot pad 14 is typically placed in a boot 15as shown or in another type of shoe able to receive the foot pad 14.Additionally, a cushion pad 16 may be placed in the boot 15 before thefoot pad 14 to provide additional protection and cushioning of the wound36.

FIGS. 5-27 show different types and sizes of padding, which can be usedas the load relieving dressing 12. The load relieving dressing 12 can bemade from any material or combination of materials that lend themselvesto providing proper support to relieve load on the wound 36. Thesematerials can soft or firm. An example of a material is felt foampadding. The load relieving dressing 12 includes a wound aperture 42 ora less dense material in place of the wound aperture 42 to relivepressure or load on and around the wound 36. The wound aperture 42 orless dense material is usually in the center of the load relievingdressing 12. In all of the figures, the wound aperture 42 is shown as ahole, but could merely be an opening which relieves the load on thewound 36. The load relieving dressing 12 shown in FIG. 5 includes around pad 44 with the wound aperture 42 cut out in the center of theround pad 44. The load relieving dressing 12 of FIG. 5 is also shownwith an adhesive layer 46 and a removable protective layer 48, whichprotects the adhesive layer 46. FIG. 6 shows the round pad of FIG. 5with the addition of an additional material 49 in the wound aperture 42.The additional material 49 has different physical properties to the pademployed, yet is beneficial to the wound 36. An example of an additionalmaterial 49 is a spongy material, which is a less dense material thenthe pad, allowing some support, yet still relieving the load on thewound 36.

FIG. 7 shows the round pad 44 of FIG. 5, whereby the adhesive layer 46is replaced with an adhesive sheet 50. The adhesive sheet 50 is attachedto the top of the round pad 44. The adhesive sheet 50 includes amedicated center 52 which fits over the wound aperture 42 and acts as anocclusive dressing. The medicated center 52 can include medication toaid in the healing of the wound 36. FIG. 8 shows the round pad 44 ofFIG. 7 with the additional material 49 in the wound aperture 42. FIG. 9shows the round pad 44 of FIG. 7, whereby the adhesive sheet 50 includesa mesh center 54 over the wound aperture 42. The mesh center 54 issimilar to bandage material to allow airflow and can be coated withmedication. FIG. 10 shows the round pad 44 of FIG. 9 with the additionalmaterial 49 in the wound aperture 42. FIG. 11 shows the round pad 44 ofFIG. 5 with the wound aperture 42 filled with medication 56 and amembrane 58 applied to the bottom of the pad 44. The membrane 58 is usedto support the medication 56 in the wound aperture 42. FIGS. 12-15 showcross-sections of the round pad concept for the load relieving dressing12, whereby the edge 60 of the wound aperture 42 in each case isdifferent. FIG. 12 also shows a different outside edge 62 for theoutside edging of the load relieving dressing 12. Different shaping ofwound aperture edge 60 and the outside edge 62 of the load relievingdressing 12 can address different types of wounds and the variety ofshapes provide for optimal pressure distribution at the periphery of thewound 36. All of the load relieving dressings 12 shown in concept inFIGS. 5-15 can be made as different shapes and sizes so that the correctdressing size and shape can be selected for wounds of different shapesand sizes.

FIG. 16 shows the foot pad 14 uncut. The uncut foot pad 14 must be sizedand cut according to the size of the foot 38 and the position of thewound 36 on the foot 38. The foot pad 14 can be made of any type ofmaterial or combinations of material which lend themselves to beinginserted into footwear. The most likely material for the foot pad 14would be a type of foam, which could be soft or firm. The foot pad 14includes the dressing opening 40 which securely receives the loadrelieving dressing 12. The dressing opening 40 is usually offset fromthe center of the foot pad 14 in the y-direction, as shown in FIG. 16.The dressing opening 40 is positioned such that there is enough materialto surround the foot 38, when the wound 36 is between the center of thefoot 38 and either the toe or heel of the foot 38. Therefore, the footpad 14 must be large enough in the x and y directions to accommodate afoot 38, regardless of the position of the wound 36. The foot 38 isplaced on the uncut foot pad 14, such that the load relieving dressing12 is inserted into the dressing opening 40, as shown in FIGS. 16-17.The outline of the foot 38 is then traced onto the foot pad 14, as shownin FIG. 17. The outline must be large enough to provide proper supportof the foot 38 and proper fit in the boot 15. As in the case of the typeof boot 15 shown in FIG. 2, the boot 15 is adjustable to accommodatemany different sizes of feet. Finally, the foot pad 14 is cut along theoutline of the foot 38 to produce a finished foot pad 14 as shown inFIG. 18. FIGS. 16-18 show placement of the foot 38 when the wound 36 isbetween the toes and the center of the foot 38. FIGS. 19-20 show adifferent positioning of the same uncut foot pad 14 in relation to thefoot 38, if the wound 36 is between the heel and the center of the foot38.

FIGS. 21-26 show the load relieving dressing 12 as a rectangular pad 64with the round wound aperture 42. As shown in FIGS. 21-26, therectangular pad 64 is attached to foot 38 and covers a greater area ofthe foot 38. The larger rectangular pad 64 provides a larger surfacearea for the patient to walk on, when the rectangular pad 64 is notinserted into the foot pad 14. This is important since it is anticipatedthat the patient will walk occasionally without the boot 15 and/or footpad 14 and such walking in a barefoot state could retard the progress ofhealing. Having a large load relieving dressing 12 such as therectangular pad 64 gives additional protection of the wound 36, when theboot 15 and foot pad 14 are not employed. The uncut foot pad 14 includesa rectangular dressing opening 40 to receive the rectangular pad 64. Theuncut foot pad 14 is large enough in the x and y directions toaccommodate a foot 38, regardless of the position of the wound 36. FIGS.21-26 show the same process for cutting out the foot pad 14, as is shownin FIGS. 16-18. FIGS. 25-27 show the positioning of the foot 38 and thecut foot pad 14, if the wound 36 is close to the side of the foot 38.Also, shown in FIGS. 21-26 are a foot pad support sheet 66 and an uncutcushion pad 16. The foot pad support sheet 66 is a sheet of flexible,yet rigid material attached to the bottom of the uncut foot pad 14.Integrity of the foot pad 14 needs to be maintained, even if the edge ofthe dressing opening 40 must be cut away from the foot pad 14 toposition the foot 38 correctly in the boot 15. The foot pad supportsheet 66 provides support to maintain the integrity of the foot pad 14in such cases. The uncut cushion pad 16 is placed under the foot pad 14before cutting, so the cushion pad 16 may be cut out to the same size asthe foot pad 14, if a pre-cut cushion pad 16 to fit the boot 15 is notprovided. FIGS. 21-26 show the placement of the foot 38, if the wound 36is between the toes and the center of the foot 38. FIGS. 27-29 show anoval shaped pad 68 used as the load relieving dressing 12 and an ovalshaped dressing opening 40 in the foot pad 14. FIGS. 27-29 also show theplacement of the foot 38, if the wound 36 is between the heel and thecenter of the foot 38.

Some of the key features of the present invention are that it provides awound healing system which allows the patient more freedom and mobility.More freedom and mobility translates to accepted use by the patientbefore the wound progresses into a wound which can not be healed. Thewound aperture 42 or the less dense material in the center of the loadrelieving dressing 12 provides the reduction of load on the wound 36,thereby aiding in the healing of the wound 36. The ability to engage anddisengage the load relieving dressing 12 from the foot pad 14 allows thepatient to remove the more bulky parts of the system, if necessary.Examples of when the foot pad 14 and boot 15 may be removed are when thepatient is resting or bathing. Under these circumstances of limitedweight-bearing, the load relieving dressing 12 itself will off-load thewound enough to permit healing, even if some steps are taken without theboot 15 and foot pad 14. The geometric shapes of the wound aperture 42,load relieving dressing 12 and the dressing opening 40 can be changed tosuit different situations and wounds.

The kit, as described above, provides an easy system for medical staffto employ in the treatment of a wound. The medical staff can simply openthe box and find all the elements necessary for wound treatment andhealing and follow an instruction manual to treat the wound. Theinstruction manual can be part of the educational materials. Basically,the kit allows the medical staff to clean the wound using the woundcleanser 28, wound treatment pads 26, surgical blade 18 and tweezers 20.The ruler 24 or other measuring instrument is used to assess the size ofthe wound and track the healing progress of the wound. The loadrelieving dressing 12 is prepared by the staff, depending of the type ofload relieving dressing 12. The most appropriate load relieving dressing12 is selected based on wound type and wound size, which include thechoices of various medicated centers. The most appropriate size andshape of the load relieving dressing 12 is selected and may be cut tosize, and preparation may include removing protective coverings andapplying medication. Then, the load relieving dressing 12 can be appliedto foot 38. After the load relieving dressing 12 is applied, the foot 38is placed on the foot pad 14 to outline the foot 38. The foot pad 14 iscut according to the outline, whereby the ruler 24 and the scissors 22are employed. If the cushion pad 16 is to be employed, it must be cut,unless it comes in the kit as a pre-cut item. The cushion pad 16 andfoot pad 14 are then placed into the boot 15, whereby the wound healingsystem 10 is ready for use by the patient. It is expected that the loadrelieving dressing 12 will be changed on a regular basis, so that thewound may be treated and examined.

While different embodiments of the invention have been described indetail herein, it will be appreciated by those skilled in the art thatvarious modifications and alternatives to the embodiments could bedeveloped in light of the overall teachings of the disclosure.Accordingly, the particular arrangements are illustrative only and arenot limiting as to the scope of the invention which is to be given thefull breadth of any and all equivalents thereof.

We claim:
 1. A method of healing a wound on a foot comprising: a.preparing the wound and an area of the foot about the wound to receive aload relieving dressing; b. assessing the wound to determine the properload relieving dressing to be employed; c. preparing the load relievingdressing to be attached to the area of the foot about the wound, wherebythe load relieving dressing provides support to the foot in the area andrelieves load on the wound; d. applying the load relieving dressing tothe area about the wound with an adhesive; and e. inserting the loadrelieving dressing into a dressing opening in a foot pad, where thedressing opening is sized to securely receive the load relievingdressing and the dressing opening and the load relieving dressing areconfigured to allow easy removal of the load relieving dressing attachedto the foot by pulling the foot away from the foot pad and where thefoot pad being a planer flat surface that is adapted to be under thefoot.
 2. The method of claim 1, further including outlining the shape ofthe foot and cutting the foot pad along the outline, where the outlineis determined by the size of the foot and footwear; and placing the footpad in footwear.
 3. The method of claim 1, further including a woundaperture as part of said load relieving dressing to relieve a loadplaced on the wound when the patient walks.
 4. The method of claim 1,further including footwear to receive said foot pad.
 5. The method ofclaim 1, further including a cushion pad to provide support for saidfoot pad in footwear.
 6. The method of claim 1, wherein said loadrelieving dressing is large enough to provide support along a width ofthe foot in said area.
 7. The method of claim 1, wherein said foot padis large enough to accommodate the foot due to placement of the wound inrelation to said load relieving dressing and said dressing opening, suchthat said foot pad can be cut to shape of the foot in order to allowsaid foot pad to fit in footwear.
 8. The method of claim 1, wherein saidload relieving dressing includes medication which contacts the wound. 9.The method of claim 1, wherein said load relieving dressing includes abandage type material which contacts the wound.
 10. The method of claim1, wherein said load relieving dressing includes a material thatcontacts the wound which is less dense than material of said loadrelieving dressing which surrounds the wound.
 11. The method of claim 1,wherein said load relieving dressing and said dressing opening areround.
 12. The method of claim 1, wherein said load relieving dressingand said dressing opening are rectangular.
 13. The method of claim 1,wherein said load relieving dressing and said dressing opening are oval.14. The method of claim 1, wherein said foot pad includes a foot padsupport sheet attached to said foot pad about said dressing opening,said foot pad support sheet at least larger than said dressing openingin order to provide support and maintain integrity of said foot pad ifsaid foot pad has a portion cut away in an area of said dressingopening.
 15. The method of claim 1, wherein said wound aperture is anopen hole.